FDA 510(k) Application Details - K002704

Device Classification Name Endoscope, Neurological

  More FDA Info for this Device
510(K) Number K002704
Device Name Endoscope, Neurological
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY, CA 90230-7600 US
Other 510(k) Applications for this Company
Contact KEVIN KENNAN
Other 510(k) Applications for this Contact
Regulation Number 882.1480

  More FDA Info for this Regulation Number
Classification Product Code GWG
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 08/30/2000
Decision Date 11/03/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact